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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC

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TISSUE SCIENCE LABORATORIES MESH TSL - PELVICOL¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNK PELVICOL
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Atherosclerosis (1728); Cellulitis (1768); Diarrhea (1811); Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Thrombus (2101); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Injury (2348); Prolapse (2475); Blood Loss (2597); Osteopenia/ Osteoporosis (2651); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of cystocele and uterine prolapse. The patient underwent a vaginal hysterectomy, anterior vaginal repair with graft placement. It was reported that after implant, the patient experienced pain, recurrent vaginal vault prolapse, discomfort, irritable bowel syndrome, fecal incontinence, dyspareunia, cystocele, enterocele, rectocele, stress incontinence, urethral hypermobility, weakened pubovaginal fascia, thick yellow and pink vaginal discharge, constipation, vaginal bulging, occasional bleeding, infected mesh, mesh extrusion, adhesions, abscess, granulation tissue, acute vaginitis, urinary urgency and frequency. Patient has history of mild urinary retention and coronary artery disease s/p cabg as well as history of pelvicol anterior colporrhaphy. Post-operative patient treatment included urethrocystoscopy, vaginoscopies, cystoscopy, anterior colporrhaphy, dermal allograft placement in the anterior compartment, tension-free vaginal tape, suburethral sling, abdominal enterocele repair, gynemesh sacrocolpopexy, extensive lysis of adhesions, excision and drainage of abdominal abscess, abdominal washout, explantation of abdominal mesh, reconstruction of the upper vaginal vault along with additional implants.

 
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Brand NameMESH TSL - PELVICOL¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB GU11 1EJ
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8454050
MDR Text Key139959278
Report Number9617613-2019-00022
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNK PELVICOL
Device Catalogue NumberUNK PELVICOL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/26/2019 Patient Sequence Number: 1
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